Inlive is an original preventive vaccine in the world, independently developed by Sinovac Biotech Ltd., which is mainly used to prevent the Hand-Foot-Month Disease(HFMD) caused by Enterovirus Type 71(EV71) under 3 years old. The research of EV71 vaccine was initiated in May, 2008.Through close collaborations with China Food and Drug Administration (CFDA), Centers for Disease Control and Prevention (CDCs) and well-known research institutions, it costed us 8 years with extensive capital investment to complete the pre-clinical research, clinical trials (Phase I - Phase III), and commercial plant. In December 2015, Inlive was approved to be commercialized in China.
Clinical trials show that Inlive is safe and effective.
The results of phase I, II, III clinical trials and lot-to-lot consistency research are published on well known academic journals, which suggest that:
1) Inlive is safe and there is no significant difference between Inlive and placebo. The adverse reactions are mainly grade I and II.
2) The protective rate of HFMD caused by EV71 is up to 94.6% and the protective rate of severe cases and hospitalization caused by EV71 is up to 100%
3) After two years of inoculation, the GMT induced by Inlive is still high-level and the protective rate of HFMD caused by EV71 is still up to 95.1%.
4) The lot-to-lot consistency is good, which illustrates that the technique and quality are stable.
- Inoculate 2 doses of Inlive as soon as possible, keep away from HFMD caused by EV71
- Usage: Deltoid intramuscular injection of the upper arm,0.5ml/dose
- Immunization Schedule: Two doses in basic immunization with one month interval.
- Target Groups For Vaccination: Susceptible people aged from 6 month to 3 years old
CDC experts in China suggest that the target groups of EV71 vaccine are the susceptible people aged above 6 month, it’s better to complete the immunization schedule within 12 month after birth.
Improve the producing technique, confirm the vaccine safety
- Stably Culture: The biggest cell culture platform in China, less operation, lower risks of pollution, better consistency, more stable quality.
- Efficient Purification: Through complex purification steps, removal rate of hybridprotein is up to 99.8%. The total protein is under 2μg/dose. High-purity vaccine ensures the safety.
- Sterile Assurance: Use enclosed pipe systems that prossess proprietary intellectual property rights to foster, inactivate, purificate virus, which ensure the sterility effectively, avoid pollution.
A dedicated production line for the EV71 vaccine is located at a campus in Changping district of Beijing. The EV71 production plan has passed the GMP inspection in December 2015. The commercial production of EV71 vaccine has been initiated since the beginning of 2016. The first few lots of vaccine have been successfully passed the lot release test by the National authority.
The Changping facility was acquired by Sinovac Beijing in February 2010. It also houses a new filling and packaging line in accordance with China new GMP standards which has been fully operational since May of 2013.